FDA sends ImmunityBio a refusal to file letter for its recent supplemental BLA submission seeking approval for Anktiva plus Bacillus Calmette-Guerin f...
Capricor Therapeutics says it has completed an FDA mid-cycle review meeting on a BLA seeking approval for deramiocel and its use in treating Duchenne ...
FDA denies a CytoSorbents de novo marketing request for its DrugSorb-ATR antithrombotic removal system, intended for reducing the severity of bleeding...
FDA clears a GE HealthCare 510(k) for its MR Contour DL, an artificial intelligence model that uses deep learning for organs-at-risk segmentation.
FDA acccepts for review a Novo Nordisk NDA for a once-daily, 25 mg oral formulation of Wegovy (semaglutide) for chronic weight management in certain o...
FDA rehires some Freedom of Information office workers who were terminated under White House-mandated reduction-in-force cuts.
FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissuing them in draft form to add changes based on undi...
A citizen petition asks FDA to restrict the off-label use of the Da Vinci Robotic System and video-assisted thoracoscopy devices to perform the hybrid...
